None listed
Conditions
Brief summary
The aim of this study is to determine whether the daily temperature profile of patients receiving a zoledronic acid infusion is improved by the administration of oral dexamethasone at the time of infusion, compared to placebo. The study will also assess whether there is a decreased incidence and/or severity of symptoms of acute phase response (APR) with oral dexamethasone compared to placebo. This is a prospective randomized-controlled trial of 40 individuals undergoing treatment with zoledronic acid for fracture prevention or Paget’s disease. Individuals meeting inclusion criteria will be randomly and equally allocated to receive either dexamethasone 4mg orally or a placebo tablet at the time of zoledronic acid infusion. Incidence and severity of the acute phase response, determined via assessment of symptoms and temperature, will be compared between groups. At baseline, each participant will undergo oral temperature measurement and will complete a questionnaire relating to symptoms of APR. Daily assessments will continue for 3 days following the intervention. .Fifteen days after the intervention, participants will receive another phone call to inquire about ongoing symptoms.
Interventions
A single dose of dexamethasone 4mg will be given as an oral tablet at the same time that the zoledronic acid infusion is started.
Zoledronic acid is conventionally given as a dose of 5mg intravenously over 15 minutes. However, it may also be given as a dose of 2.5mg over 30-45 minutes in patients with mild renal impairment. The decision regarding dose and duration of zoledronic acid infusion will be made by the treating physician prior to study enrollment.
To facilitate data collection, parti
A single dose of dexamethasone 4mg will be given as an oral tablet at the same time that the zoledronic acid infusion is started. Zoledronic acid is conventionally given as a dose of 5mg intravenously over 15 minutes. However, it may also be given as a dose of 2.5mg over 30-45 minutes in patients with mild renal impairment. The decision regarding dose and duration of zoledronic acid infusion will be made by the treating physician prior to study enrollment. To facilitate data collection, participants will receive telephone calls from a study investigator one day, four days, and fifteen days following this intervention.
Sponsors
Bone & Joint Research Group, University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Females or males aged 20 or older. Prescribed zoledronic acid for the first time for fracture prevention or Paget's disease.
Exclusion criteria
Prior treatment with zoledronic acid. History of fever, infection, or influenza-like illness within the past week. Diabetes mellitus or uncontrolled hypertension (BP >160/90) Treatment with glucocorticoids within the past week. History of adverse reaction to glucocorticoids. Major systemic illness, including malignancy.
Outcome results
None listed